Detection of RNA of ORF1ab region of coronavirus SARS-CoV-2.
Detection of the new SARS-CoV-2 variant from the UK B1.1.7 (VOC-202012/01), the Delta variant and the variant from South Africa B.1.1.529.
Background: Coronaviruses are positive single-stranded RNA viruses of the family Coronaviridae. Several different strains of coronaviruses are currently known to infect humans (HCoV-229E, HCoV-NL63, HCoV-OC43, HCoV-HKU1, MERS-CoV, SARS-CoV, SARS-CoV-2, NCoV and HCoV-EMC). Strains HCoV-229E, HCoV-NL63, HCoV-OC43, MERS-CoV and HCoV-HKU1 cause cold, upper respiratory infection, bronchiolitis and pneumonia in humans. SARS-CoV, a beta coronavirus, causes the Severe Acute Respiratory Syndrome (SARS). SARS-CoV-2 is a beta coronavirus that emerged in Wuhan, China in December 2019. The virus is responsible for the disease COVID-19 (corona virus disease 2019). Fever, cough and breathing difficulties are described as the most frequent initial symptoms, later on it can lead to pneumonia. The main route of SARS-CoV-2 transmission is via respiratory uptake of virus particles (droplets or smaller aerosols).
Description: ViroReal® Kit RT-LAMP SARS-CoV-2 is an in vitro diagnostic test based on one-step RT-LAMP technology for the detection of RNA of SARS-CoV-2. This test is used as a screening tool for samples from patients of all age groups with and without suspected COVID-19 disease. The test takes between 30-53 minutes, depending on the (real-time) PCR device used. The test is suitable for the detection of SARS-CoV-2 of persons who are in an infectious stage. Samples with an RNA concentration of approximately 20,000 copies per ml or more (equivalent to approximately 100 copies per RT-LAMP reaction, which corresponds to a real-time PCR Cq value of approx. 31) can be reliably detected with a sensitivity of 95% and a specificity of 99%.
The results of ViroReal® Kit RT-LAMP SARS-CoV-2 represent a snapshot of the infection status of the tested person and should not be used as the sole basis for patient management decisions. Persons with a positive or questionably positive test result should be retested by real-time PCR (gold standard).
This test can either be used with native specimens (without prior extraction) or with extracted RNA. Proper native specimens are oropharyngeal swabs (posterior throat swabs) in 2 ml of isotonic saline solution (NaCl 0.9%), solely. There is no need for RNA extraction, because virus inactivation and lysis occur during the isothermal amplification step. Caution: Other native specimens or transport media are not suitable. Suitable purified (extracted) test materials are samples from the upper respiratory tract (throat rinsing fluid, nasopharyngeal and oropharyngeal swabs, nasopharyngeal wash/aspirate and nasal aspirates). This test material must be prepared with a suitable RNA extraction procedure before testing.
- Amplification and detection: ORF1ab region of SARS-CoV-2
- One-step RT-LAMP technology
- Detection of amplification via amplification curve and melting curve. Additionally colorimetric detection of amplification by change of color from red to yellow
- Inhibited activity at room temperature
- PCR- platforms: runs on all established standard real-time PCR- platforms and conventional block-PCR instruments
- Available formats: Kit (with reaction mix)